SUPPLY CHAIN ARTICLES
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![Cell transfection with plasmid GettyImages-1290924802]( "Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why")
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's WhyThe demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
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![GettyImages-1269045566-rna]( "The Expanding Patent Landscape For RNA-Based Therapeutics")
The Expanding Patent Landscape For RNA-Based TherapeuticsThe COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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![GettyImages-1459917555-lab-research-development-gene-genetic]( "The mRNA Supply Chain Revolution: Materials, Methods, And Momentum")
The mRNA Supply Chain Revolution: Materials, Methods, And MomentummRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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![Talimogene laherparepvec vaccine-GettyImages-960686030]( "Addressing Challenges In Serialization For Complex Therapeutics")
Addressing Challenges In Serialization For Complex TherapeuticsThe magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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![GettyImages-96831350]( "“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles")
“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP PrinciplesIn the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
SUPPLY CHAIN VIDEOS
In this opening Advancing RNA Live clip, panelists Max De Long, April Sena, and Venkat Krishnamurthy share the biggest scientific and manufacturing breakthrough made in the world of gRNA production over the past year.
In this Advancing RNA Live segment, several speakers raise concerns about the industry's ability to accurately measure impurities, particularly dsRNA, arguing that current analytics are insufficient, especially for high-dose therapeutics.
The oligo manufacturing paradigm is facing several different evolutions whether it be the transition to liquid-phase or hybrid synthesis. In this Advancing RNA Live clip, Camp4’s Satya Kuchimanchi explores how these manufacturing advancements are impacting our supply chain needs.
Learn more about CustomBiotech's mRNA raw materials pipeline and strict quality criteria that are designed to support the success of our customers’ manufacturing scale-up and regulatory drug approval.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1297146235-dna]( "Review Of mRNA Vaccines & Therapeutics Manufacturing Challenges: Plasmid DNA Manufacturing")
This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
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![iStock-528606286-handshake-partnership-partner-agreement]( "Transitioning From Using RUO To cGMP Chemicals For Clinical Trials")
Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Supercharge Your Supply Chain: Harness AI To Gain Competitive Advantage")
The success of CGTs hinges upon adherence to specific logistics protocols. Learn how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.
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![Thermo ABM pic]( "Delivering Global Media Manufacturing Consistency Through Site-To-Site Equivalency")
Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
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![Cryopreservation GettyImages-172640159]( "Integrate Cryopreservation Into the End-To-End Supply Chain")
Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.
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![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
